UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the reasons for withdrawal from long-term treatment with mirabegron of treatment-naive Japanese female patients with overactive bladder in the real-world clinical setting
Acronym	Reasons for withdrawal from mirabegron for OAB
Scientific Title	Investigation of the reasons for withdrawal from long-term treatment with mirabegron of treatment-naive Japanese female patients with overactive bladder in the real-world clinical setting
Scientific Title:Acronym	Reasons for withdrawal from mirabegron for OAB
Region	Japan

Condition
Condition	Overactive bladder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The persistence of treatment with mirabegron and the reasons for withdrawal from the treatment among treatment-naive Japanese female patients with overactive bladder were prospectively investigated for 3 years in the real-world clinical setting
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The reasons for withdrawal from the treatment with mirabegron of treatment-naive Japanese female patients with overactive bladder
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Post-menopausal treatment-naive Japanese female patients who visited the hospital for the symptoms of OAB and were clinically diagnosed with OAB
Key exclusion criteria	Patients with premenopausal, urinary tract infection, large postvoid residual volume (more than 150 mL), a previous treatment history for OAB, and contraindications to use of mirabegron
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Yoshinori Middle name Last name Tanaka
Organization	Hokkaido Prefectural Esashi Hospital
Division name	Division of Urology
Zip code	043-0022
Address	484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido, Japan
TEL	0139-52-0036
Email	rinoshiyokanata@me.com

Public contact
Name of contact person	1st name Yoshinori Middle name Last name Tanaka
Organization	Hokkaido Prefectural Esashi Hospital
Division name	Division of Urology
Zip code	043-0022
Address	484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido, Japan
TEL	0139-52-0036
Homepage URL
Email	rinoshiyokanata@me.com

Sponsor
Institute	Hokkaido Prefectural Esashi Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Hokkaido Prefectural Esashi Hospital
Address	484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido, Japan
Tel	0139-52-0036
Email	hofuku.esabyo2@pref.hokkaido.jg.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 09 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 23 Day
Date of IRB	2011 Year 09 Month 23 Day
Anticipated trial start date	2011 Year 10 Month 03 Day
Last follow-up date	2017 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Patients visited the hospital between October 2011 and July 2014

Management information
Registered date	2017 Year 09 Month 07 Day
Last modified on	2019 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033212